Expired Study
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Fort Deterick, Maryland 21702


Purpose:

This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.


Study summary:

Study Objectives: Primary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92. Secondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.


Criteria:

Inclusion Criteria: - 18-55 years of age - In good health as determined by pertinent medical history, brief physical exam, vital signs, and clinical safety laboratory evaluations - Female: has a negative urine pregnancy test and is willing to use reliable form of contraception for the study duration - Negative HIV antibody screen, seronegative for HBsAg and Hepatitis C antibody - WEE, EEE, VEE, and CHIK PRNT80<1:10 - Ability to comprehend abnd a willingness to sign an informed consent, which includes the HIPAA and a separate HIV consent form - Be willing to comply with all follow-up visits, testing, and AE reporting Exclusion Criteria: - Participant in the USAMRIID SIP - Receipt of any other vaccine or investigational; drug within 30 days prior to study entry - Anticipates receipt of other vaccines for the duration of the study (influenza vaccination will be permitted but not within 28 days of WEE vaccination - Acute of chronic medical conditions, medications, or dietary supplements that, in the PI's opinion, would impair the subject's ability to respond to vaccination - Hypersensitivity to any vaccine - Allergic to any vaccine component: Human serum albumin, Neomycin - Receipt of or anticipates receipt of blood products during the study - Female: Pregnant or breastfeeding - Clinically significant abnormal laboratory tests (generally greater than or equl to 2 times the upper limit of normal as determined by the PI)


NCT ID:

NCT01159561


Primary Contact:

Principal Investigator
Ronald B Reisler, MD
USAMRIID Medical Division


Backup Contact:

N/A


Location Contact:

Fort Deterick, Maryland 21702
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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